Sight Sciences confirms long-term effectiveness of OMNI System for Glaucoma

Sight Sciences, Inc. an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, announced the publication of a landmark 36-month analysis evaluating the long-term effectiveness of the OMNI® Surgical System  in managing primary open-angle glaucoma.

This real-world study, led by Nathan M. Radcliffe, MD, of Mount Sinai School of Medicine in New York City, evaluated 230 eyes of 196 patients with POAG through up to 36 months. The results demonstrate clinically and statistically significant reductions in intraocular pressure (“IOP”) through up to 36 months postoperatively, with mean reductions ranging from 5.6 to 7.1 mmHg. The study also reports a statistically significant decrease in medication use through 18 months. Eyes with lower baseline IOP experienced medication reduction through 36 months.

“There is a growing interest in using minimally invasive glaucoma surgery (“MIGS”) as a standalone procedure for patients with pseudophakic or precataractous eyes,” said Nathan M. Radcliffe, MD, lead investigator of the study and Associate Professor at the Mt. Sinai School of Medicine in New York. “This analysis represents one of the most comprehensive, real-world evaluations of standalone canaloplasty and trabeculotomy in these patient populations to date. Our findings underscore the ability of OMNI to achieve significant and sustained reductions in IOP and medication use over three years, reinforcing its position as a highly effective interventional treatment for patients with primary open-angle glaucoma.”

Key Study Findings:

• Sustained IOP Reduction: Mean (SD) baseline IOP was 22.1 (6.4) mmHg. Over 36 months of follow-up, mean IOP ranged from 15.1 to 16.7 mmHg (p<0.0001 at every time point compared to baseline), with average eye-level reductions of 5.6 to 7.1 mmHg.
• Greater IOP Reductions in High Baseline IOP Patients: Subgroup analysis showed even greater IOP reductions (up to 8.9 mmHg) in patients with baseline IOP greater than 18 mmHg. Eyes with lower baseline IOP (<18 mmHg) had reductions in medication use through 36 months, and eyes with higher baseline IOP (>18 mmHg) had statistically significant reductions in IOP and reductions in medication use through 36 months.
• Reduced Medication Dependence: The study observed a notable decrease in the need for IOP-lowering medications, reducing patient dependence on adherence-prone therapies. The mean number of glaucoma medications used at baseline was 2.1 (1.5) and ranged from 1.1 to 1.6 medication classes between months 6 and 36, with statistically significant decreases in utilization through 18 months postoperatively (p<0.0011).

Paul Badawi, President and CEO of Sight Sciences added, “We are excited to see such compelling evidence highlighting OMNI’s long-term impact. This study further strengthens the extensive body of clinical data that supports the safety and efficacy of the OMNI procedure. It reinforces our commitment to delivering innovative, data-driven interventional technologies that empower physicians to elevate patient care. OMNI continues to set new standards in minimally invasive glaucoma surgery, driving our mission to transform eyecare for the millions affected by glaucoma.”

The OMNI Surgical System enables an implant-free, ab interno MIGS procedure intended to restore aqueous outflow of glaucomatous eyes by addressing the three areas of outflow resistance associated with the disease. This retrospective, observational cohort study of the procedure drew data from the IRIS Registry, the first comprehensive eye disease clinical registry in the United States. Launched in 2014, it has amassed over 851 million patient encounters and 80 million unique de-identified patients from nearly 30 electronic health records systems (EHRs) and 15,000 ophthalmologists and other eye care professionals across the U.S., as of July 1, 2024.